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Learning unitInformed Consent

Introduction

In empirical research projects, it is generally necessary to obtain informed consent, which provides participants with detailed information about the research project and explicitly requests their approval. Consent can be obtained in either written or oral form. However, since there is a legal requirement to provide proof of consent, the written form is often recommended.

Informed consent serves multiple purposes: On the one hand, it is part of legal data protection requirements when processingThe term 'processing' is defined as 'any operation or set of operations which is performed on personal data or on sets of personal data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction;' (BlnDSG §31, 2020; EU GDPR Article 4 No. 2, 2016). Processing therefore refers to any form of working with personal data, from collection to erasure. Read More personal dataPersonal data includes: 'any information relating to an identified or identifiable natural person (data subject); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier, or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural, or social identity of that natural person(…)” (EU GDPR Article 4 No. 1, 2016; BDSG §46 para. 1, 2018; BlnDSG §31, 2020). Read More and protects the individual’s right to decide on the disclosure and use of their given information. Data protection and the protection of personal rights are therefore closely linked to aspects of anonymization or pseudonymization (see article Anonymization and Pseudonymization). On the other hand, it is an essential principle of research ethics and respects the autonomy and self-determination of research participants. The affected individuals are informed about the objectives and methodology of the research/study, as well as their rights and potential risks associated with participation. Based on this information, research participants can freely decide whether they wish to take part in the research project.

For social and cultural anthropologists, it is particularly relevant to avoid an ethnocentric perspective on research ethics and to adapt informed consent to the respective research context.

Requirements for a valid informed consent:

1) Information, Decision-Making Competence, and Capacity to Consent

To exercise their right to self-determination and assess the potential consequences of their consent, affected individuals must understand what they are confirming with their signature. Informed consent should therefore be transparent, comprehensible, and formulated appropriately for the respective target group, including all relevant information without overwhelming or deterring participants.

Linguistic, cultural, and/or age-related comprehension barriers must be considered to enable participants to make a genuinely informed decision. Furthermore, legal regulations regarding age of consent must be observed. In Germany, parental consent is required for minors up to the age of sixteen. In such cases, both the minors and their legal guardians must provide consent. For other national contexts, the legal age threshold for independent consent may vary (Verbund FDB, 2019).

2) Voluntariness

Informed consent is only valid if it is given voluntarily, without coercion or pressure. Research participants must be free to choose whether and to whom they allow data collection and processing. It is thus essential to inform the affected individuals that informed consent can be withdrawn or refused at any time. However, withdrawal only takes effect from the moment it is declared, as „data processing activities that have already taken place based on valid consent are not affected by withdrawal.“1Translated by Saskia Köbschall. (Schaar, 2017, p. 6)

3) Purpose Specification

Informed consent is given by participants for one or more specific purposes, which should be „as specific as necessary and as general as possible.“2Translated by Saskia Köbschall. (Verbund FDB, 2019, p. 6) This results in consent options that allow participants to decide whether their personal data may be made available beyond the current research project, e.g., for archiving and reuse. If the purposes of data processing change significantly during the research project (e.g., due to a new research question), a new, adapted consent must be obtained from the affected individuals. It is crucial to specify all steps of the intended data use and processing in a transparent, complete, and precise manner, as otherwise, restrictions or complications may arise in data use, archiving, or reuse.

It can be summarized as follows:

„Informed consent requires that study participants are made aware of the essential aspects of the research project, that their consent is given for a specific purpose, and that they have been informed that they may revoke their voluntarily given consent at any time“.

(Trixa & Ebel, 2015, p. 12)3Translated by Saskia Köbschall.